BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM

    MDR report key: 14437850 · Received May 19, 2022

    Report

    Report Number
    1000306051-2022-00094
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    June 3, 2021
    Report Date
    July 6, 2022
    Product Code
    FTM
    UDI-DI
    00818410010096
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION INTO STRATTICE LOT SP200172 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS. THE INVESTIGATION RESULTED IN NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO DEVIATIONS OR RELATED NON-CONFORMANCES REVEALED DURING PROCESSING. THE LOT WAS TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. AS OF 4/28/22, OF THE (B)(6) DEVICES RELEASED TO FINISHED GOODS FOR LOT SP200172, (B)(6) HAVE BEEN DISTRIBUTED WITH (B)(6) REPORTED AS IMPLANTED. LOT SP200172 WAS PROCESSED ASEPTICALLY, TERMINALLY STERILIZED AND MET ALL QC RELEASE CRITERIA.. BASED ON OUR INTERNAL REVIEW WITH NO REMARKABLE FINDINGS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. NO FURTHER ACTIONS ARE REQUIRED AS A NONCONFORMANCE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE INDIVIDUAL PIECE THAT WAS IMPLANTED FROM LOT SP200172 WAS IDENTIFIED AS PIECE 075. THE INVESTIGATION CONCLUSION THAT WAS REPORTED IN THE INITIAL MEDWATCH THAT IS ASSOCIATED WITH LOT SP200172 REMAINS THE SAME. THE INVESTIGATION WAS PERFORMED ON THE ENTIRE LOT AND THE PIECE NUMBER WAS INCLUDED WITHIN THE INVESTIGATION. THE RELATIONSHIP TO THE STRATTICE REMAINS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION INTO STRATTICE LOT SP200172 INCLUDED A REVIEW OF THE REPORTED INFORMATION, REVIEW OF THE DEVICE HISTORY RECORDS, AND A REVIEW OF THE COMPLAINT HISTORY RECORDS. THE INVESTIGATION RESULTED IN NO REMARKABLE FINDINGS, INCLUDING NO OTHER COMPLAINTS REPORTED AGAINST THE LOT AND NO DEVIATIONS OR RELATED NON-CONFORMANCES REVEALED DURING PROCESSING. THE LOT WAS TERMINALLY STERILIZED WITHIN THE PROCESS PARAMETERS AND MET ALL QC RELEASE CRITERIA. AS OF (B)(6) 2022, OF THE 136 DEVICES RELEASED TO FINISHED GOODS FOR LOT SP200019, 132 HAVE BEEN DISTRIBUTED WITH 78 REPORTED AS IMPLANTED. BASED ON OUR INTERNAL REVIEW WITH NO REMARKABLE FINDINGS, A RELATIONSHIP BETWEEN THE STRATTICE AND THIS EVENT COULD NOT BE DETERMINED. NO FURTHER ACTIONS ARE REQUIRED AS A NONCONFORMANCE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP#2 TO REPORT PMQA WAS MADE AWARE 7/8/22 THAT THE DHR INVESTIGATION WAS PERFORMED ON THE WRONG LOT INADVERTENTLY AND THIS FOLLOW UP IS TO REPORT THE INVESTIGATION CONCLUSION ON THE CORRECT LOT. AS REPORTED IN FOLLOW UP#1: THIS IS FOLLOW UP# 1 TO REPORT ON JUNE 16, 2022, PMQA RECEIVED AN EMAIL FROM LEGAL THAT INDICATED THE SUBLOT NUMBER ASSOCIATED WITH THIS EVENT IS -075. THE SERIAL NUMBER HAS BEEN UPDATED TO (B)(6) . AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 49 YEAR OLD FEMALE PATIENT UNDERWENT OPEN REPAIR OF VENTRAL/INCISIONAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2020. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH, ITEM 1010002, LOT SP200172 IN HER. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT JUNE 3, 2021 AND WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA. ON OR ABOUT (B)(6) 2021, SHE UNDERWENT OPEN REPAIR OF RECURRENT VENTRAL/INCISIONAL HERNIA WITH MESH AND LEFT AND RIGHT MYOCUTANEOUS MUSCLE RELEASE FOR COMPONENT SEPARATION.

    Description of Event or Problem · 0

    THIS IS FOLLOW UP# 1 TO REPORT ON JUNE 16, 2022, PMQA RECEIVED AN EMAIL FROM LEGAL THAT INDICATED THE SUBLOT NUMBER ASSOCIATED WITH THIS EVENT IS -075. THE SERIAL NUMBER HAS BEEN UPDATED TO (B)(6). AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 49 YEAR OLD FEMALE PATIENT UNDERWENT OPEN REPAIR OF VENTRAL/INCISIONAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2020. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH, ITEM 1010002, LOT SP200172 IN HER. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT JUNE 3, 2021 AND WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA. ON OR ABOUT (B)(6), 2021, SHE UNDERWENT OPEN REPAIR OF RECURRENT VENTRAL/INCISIONAL HERNIA WITH MESH AND LEFT AND RIGHT MYOCUTANEOUS MUSCLE RELEASE FOR COMPONENT SEPARATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A (B)(6) FEMALE PATIENT UNDERWENT OPEN REPAIR OF VENTRAL/INCISIONAL HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2020. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE FIRM MESH, ITEM 1010002, LOT SP200172 IN HER. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021 AND WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA. ON OR ABOUT (B)(6) 2021, SHE UNDERWENT OPEN REPAIR OF RECURRENT VENTRAL/INCISIONAL HERNIA WITH MESH AND LEFT AND RIGHT MYOCUTANEOUS MUSCLE RELEASE FOR COMPONENT SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393562 STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL FTM SP200172 00818410010096

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention NO INFORMATION REPORTED.